ActivBiotics to Present Results of Pivotal Study in the Treatmentof Peripheral Arterial Disease at AHA MeetingEnrollment completed in separate Phase II study in Carotid Atherosclerosis
LEXINGTON, Mass., October 24, 2007 /PRNewswire/ -- ActivBiotics, Inc. today announced that the results of its pivotal clinical trial (PROVIDENCE-1) studying the effect of rifalazil in the treatment of intermittent claudication associated with peripheral arterial disease (PAD) will be presented on November 7, 2007 at 11:45 a.m. EST at a late breaker Scientific Session at the American Heart Association's 2007 annual meeting being held in Orlando, Florida. Michael R. Jaff, DO, FACP, FACC, Assistant Professor of Medicine, Harvard Medical School and Medical Director, Massachusetts General Hospital Vascular Center, Boston, Massachusetts, Chair of the trial's Steering Committee, will be presenting.
PROVIDENCE-1 (Prospective Evaluation of Rifalazil Effect on Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients) is the first of two planned Phase III clinical trials to study the ability of rifalazil to improve symptoms in patients suffering from intermittent claudication, an often debilitating and under diagnosed manifestation of PAD. The prospective, double-blind, randomized, placebo- controlled trial evaluated the efficacy and safety of rifalazil in 297 patients from the United States, Russia and Brazil. The FDA has granted rifalazil Fast Track designation for development in this indication.
In addition to the PROVIDENCE-1 Phase III clinical trial, a Phase II study to evaluate the effect of rifalazil on the progression of carotid artery atherosclerosis has completed its target enrollment of 72 patients. The RESTORE-IT trial (Randomized Evaluation of Short-Term Rifalazil Treatment on Carotid Atherosclerosis and Intima Media Thickness) is a prospective, randomized, double-blind, placebo-controlled, multi-center study of patients with a clinical history of atherosclerosis and image-detectable carotid disease. This study will use the non-invasive imaging techniques of combined high-resolution magnetic resonance imaging and ultrasound to assess the degree of architectural changes in the carotid artery brought about by rifalazil treatment. The presence and progression of carotid disease are strongly correlated with an increased incidence of cardiovascular and stroke events.
Chlamydia pneumoniae infection of the vascular system has long been thought to play a role in accelerating the course of vascular disease potentially by increasing inflammation in the arterial wall thus leading to exacerbation of atherosclerosis, which could reduce blood supply to target limbs and organs.
About ActivBiotics, Inc.
ActivBiotics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of therapies for the treatment of inflammatory diseases and bacterial infections.
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Posted: October 2007